Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000212358
Ethics application status
Approved
Date submitted
2/04/2008
Date registered
18/04/2008
Date last updated
18/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of hypothermia in the delivery room for preterm infants <30 weeks gestation
Scientific title
A comparison of plactic wrap and conventional method at birth in infants <30 weeks gestation in the prevention of hypothermia in the delivery room.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothermia 2984 0
Condition category
Condition code
Other 3134 3134 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will have two groups: control and experimental. In the experimental group a plastic wrap will be used after birth, in the control group will remain standard procedure. The duration of the intervention will be 120 minutes from birth.
Intervention code [1] 2723 0
Treatment: Devices
Comparator / control treatment
Standard care after birth, as recommended by the American Academy of Pediatrics (AAP).
The control treatment will be until 120 minutes from birth.
Control group
Active

Outcomes
Primary outcome [1] 4018 0
Prevention of hypothermia
Timepoint [1] 4018 0
Temperatures will be taken at birth and then every 30 minutes until the neonate is 120 minutes old. A thermometer will be used to measure the axilla temperature of each neonate.
Secondary outcome [1] 6768 0
Hypoglycaemia, this will be measured by the blood gas machine.
Timepoint [1] 6768 0
Within the first 120 minutes of birth

Eligibility
Key inclusion criteria
Neonatal population from birth
Minimum age
30 Weeks
Maximum age
30 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 808 0
4814

Funding & Sponsors
Funding source category [1] 3248 0
Hospital
Name [1] 3248 0
The Townsville Hospital
Country [1] 3248 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
Angus Smith Drive
Douglas TSV QLD 4814
Country
Australia
Secondary sponsor category [1] 2904 0
None
Name [1] 2904 0
Address [1] 2904 0
Country [1] 2904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5232 0
Townsville Health Service District
Ethics committee address [1] 5232 0
The Townsville Hospital
Angus Smith Drive
Douglas Townsville QLD 4814
Ethics committee country [1] 5232 0
Australia
Date submitted for ethics approval [1] 5232 0
Approval date [1] 5232 0
16/09/2005
Ethics approval number [1] 5232 0
44105

Summary
Brief summary
To investigate whether the short term use of plasctic occlusive wrapping on premature neonates, immediately after delivery, is an effective method in preventing hypothermia during resuscitation in the delivery room and operating theatre. These babies are at higher risk of hypothermia, which can significantly increase both morbidity and mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28481 0
Address 28481 0
Country 28481 0
Phone 28481 0
Fax 28481 0
Email 28481 0
Contact person for public queries
Name 11638 0
Jacqueline Smith
Address 11638 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
Douglas TSV QLD 4814
Country 11638 0
Australia
Phone 11638 0
+61 7 47963472
Fax 11638 0
Email 11638 0
jacquelinej_smith@health.qld.gov.au
Contact person for scientific queries
Name 2566 0
Dr Gary Alcock
Address 2566 0
The Townsville Hospital
Neonatal Unit
Angus Smith Drive
Douglas TSV QLD 4814
Country 2566 0
New Zealand
Phone 2566 0
+61 7 47965462
Fax 2566 0
Email 2566 0
gary_alcock@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.